Paul S.
Chan, MD, MSc is Associate Professor of Medicine
at the University of Missouri, Kansas City
and a clinical cardiologist with Saint Luke's
Mid America Heart and Vascular Institute.
In this interview with Angioplasty.Org,
Dr. Chan discusses his team's recent study, "Appropriateness
of Percutaneous Coronary Intervention"1 which
was published in the Journal of the American
Medical Association
(JAMA) on July 5, 2011.
Dr. Chan gives background on the study
itself, the import of its findings and his
concerns
over the way the study may be interpreted.
Dr. Chan served as lead author of a group of
a dozen leading cardiologists to issue this
first
report
on
the issue of PCI appropriateness
since the multi-disciplinary 2009 PCI Appropriate
Use Criteria (AUC)2 were
published -- it will no doubt serve as the
benchmark for further exploration
of the appropriate use of stents and angioplasty
in the United States. |
|
Paul
S. Chan, MD, MSc |
Q: Tell us about the genesis of your
study of PCI Appropriateness1 and who was involved
in writing it.
Dr. Chan: There have been several studies historically
that have looked at the appropriateness of angioplasty
using different criteria, but oftentimes they would
adjudicate based on criteria that were author-based,
or that were limited in terms of collection of information
of symptoms and non-invasive test results. When the
Appropriate Use Criteria (AUC) for coronary revascularization,
sponsored by the national societies, such as SCAI
and ACC, were developed and were subsequently published
in January of 2009, we as a group decided that it
would be important and informative to get a better
sense of the contemporary rates of PCI appropriateness,
using these more standardized criteria.
The group was really developed to have a diversity
of players, so it wouldn't be driven by interventionalists
who may have a particular angle to the story or,
for that matter, non-interventionalists: we wanted
a balanced perspective. For example, I'm a clinical
cardiologist. So we engaged people who had been involved
in the development of the criteria or in the leadership
of the ACC and SCAI to collectively draft this document.
And we thought this would be particularly helpful
in the context of more recent reports of individuals
in the press that seemed to highlight maybe blatant
overuse of angioplasty procedures.
Q: These appropriateness
criteria were written in 2009. Two years earlier,
when the COURAGE study came out, it seemed that
there was a sort of split between cardiologists: "Should
we use drugs or stents? There’s no difference.
Angioplasty is being radically overused,” and
so on. So were you surprised by the numbers in
your study, compared to what had been estimated
previously?
"There
were predictions after COURAGE as to whether
or not angioplasties were in fact 50% inappropriate,
whereas we found a much lower rate in the
elective setting, of about 12%." |
|
Dr. Chan: Sure.
If the Appropriate Use Criteria were based on
the COURAGE trial itself only, then I think we
probably would have different numbers. The COURAGE
trial was certainly in the mindset of the technical
panel that developed the ratings for each of
the clinical scenarios, but it was not the sole
criterion, although medical therapy certainly
plays an important role in understanding whether
or not procedural appropriateness would be appropriate
in certain circumstances. There were predictions
after COURAGE as to whether or not angioplasties
were in fact 50% inappropriate, whereas we found
a much lower rate in the elective setting, of
about 12%. If the appropriate use criteria were
just developed based on the COURAGE criteria,
I think certainly that the quote-unquote "inappropriate" or
whatever you want to call it rate would be higher,
but that's an important distinction, to make
sure that people understand that these criteria
are not an extension of the COURAGE trial in
and of itself, that they really reflect the totality
of both clinical trial evidence and expert opinion
as to when angioplasty might be beneficial to
patients. |
Q:
Speaking of COURAGE – that was about
stable elective patients only, not acute or
emergency situations, but the headlines in
the mass media shouted “Stents Don’t
Work” and didn’t really
discern the very important difference
between
acute and non-acute scenarios, doing
a disservice
to patients.
Dr. Chan: Yeah.
I think, the clarity, the distinction between
acute and non-acute is a difficult one for non-medical
people to understand, and certainly lay people,
and I think we probably should be describing
the difference as "heart attacks” and “non-heart-attack-related
syndromes." Because I think people understand
what a heart attack is, but "acute" is
less familiar to the majority of not only journalists,
but also people who will be hearing about our
study. |
|
"You
can see the press potentially saying, '50%
of elective angioplasties are not appropriate….'
And that IS a misinterpretation!" |
We also worry about whether or
not the focus will be less on the “inappropriate” rate,
but more on the “not appropriate” rate
(Ed. Note: “not appropriate” means “inappropriate
plus uncertain”) --- meaning you can see the
press potentially saying "50% of elective angioplasties
are not appropriate…." And that IS a misinterpretation
of the terms!
Unfortunately, the terms that are
used in the criteria are very difficult. They have
lay interpretations; people understand "inappropriate" and "appropriate" in
very different ways, and I'm certain, for that matter,
that people might misinterpret as not having any
benefit altogether, whereas it's really that the
body of clinical evidence is just not overwhelming
enough to suggest that there's conclusive benefit,
but there is likely to be some benefit, especially
in that large number of patients with “uncertain” procedures.
So that's where I think our worry about where the
press might take this will be.
What I think we want to really
focus on is the fact that the “appropriate” procedures
really suggest a definitive or probable benefit, “uncertain” procedures
really suggest a possible benefit, and “inappropriate” procedures
suggest that there's unlikely to be benefit. That
doesn't mean that there's no circumstance when an
inappropriate patient has no benefit; it means that,
on a population average, patients who have inappropriate
procedures are not going to gain as much in terms
of symptom benefit or health status improvement as
patients who had a clinical and appropriate procedure.
Q: Right after COURAGE, most of the interventional
cardiologists I spoke with said that the COURAGE
trial, which looked at stable patients only, would
not change their practice since the majority of angioplasties
they did were in acute patients. And here we are
four years later, and they were right -- that's pretty
much what the results of your study show: 71% of
angioplasties were done for acute cases. Did that
surprise you as well?
Dr. Chan: Yeah, we were certainly not anticipating
that a little bit more than two-thirds of procedures
that we mapped would be acute. Part of it I think
is the fact that we had to exclude a number of cases,
a hundred thousand or so, primarily in the elective
setting, because we did not have information on stress
testing -- either those patients went straight to
angiography without stress testing beforehand, or
there was no documentation of what the stress test
result was. So, if we had actually included those,
we probably would have seen a closer to 50/50 split
of acute and non-acute procedures.
As to whether the rates of inappropriate and appropriate
and uncertain PCI really reflect the totality of
the procedures that were elective in the registry,
unfortunately, we just don't have enough information
from those excluded procedures to better know whether
or not they would have been appropriate. We did look
at it, but we didn't really describe in the paper,
and I suspect that some people will describe this
subsequently.
Q: Besides stress testing, how did you factor in
other imaging modalities, for example Cardiac CT,
Intravascular Ultrasound (IVUS) and Fractional Flow
Reserve (FFR)?
Dr. Chan: We actually excluded patients that had
CT angio, or just coronary calcium testing, because
they didn't really have an ischemia assessment, and
we couldn't map the patients unless they had some
sort of ischemia evaluation. As for FFR -- the clinical
scenarios in the Appropriate Use Criteria did ask
about patients who had less than 70% stenosis and
the use of FFR and IVUS, but it did not ask for FFR
data in patients who had 70% or greater stenoses,
so those patients would have been excluded because
they didn't have an ischemia evaluation.
Q: Interesting since,
if an FFR was done during the diagnostic cath
and
PCI was then performed, the
procedure would have been “appropriate” because,
according to the FAME study, FFR is an important
tool for evaluating whether a blockage is causing
ischemia or not.
Dr. Chan: Ultimately, we may need the Appropriate
Use Criteria Version 2.0 that incorporates FFR in
patients who didn't have a prior stress testing,
but had a 70% stenosis and then subsequently an FFR
during the procedure. We were aware of the FAME results,
and we certainly could have mapped those procedures
had they been assigned a rating in the Appropriate
Use Criteria, but we did not feel that we should've
assigned those ratings ourselves.
Q: About the diagnostic
pathway to the cath lab, there's been a lot of
controversy
about patients
who do not get stress testing first, but they have
symptoms, or the physician just says "go get
an angio and, if there’s a blockage, we’ll
open it up.” This ad-hoc angioplasty is a big
change from the early days when you did a diagnostic
cath, stopped, looked at it, discussed with the patient,
perhaps with a surgeon, and waited a few days or
a week or a month before going ahead with the intervention.
Dr. Chan: Yeah
-- I don't know what the media and the lay press
will do with our paper and how they'll interpret
it but, if there are huge concerns about rates
of inappropriate procedures even in the elective
settings, the real question in terms of quality
improvement can't just lie at the feet of the
interventionalists. Because oftentimes they're
referred a lot of these patients, for varying
reasons, and they don't know these patients,
by and large. So their job has been, historically,
to perform the angiogram and then proceed to
PCI if it seems reasonable. And sometimes the
rationale for going to angiography may be very
well-based: the patients may have severe ischemia. |
|
"The
real question in terms of quality improvement
can't just lie
at the feet of the interventionalists. We
need to engage the referral physician base...we
should really get patients involved in the
decision-making process
itself, and really get general cardiologists
to feel like they're part of the process of treatment." |
But I think there is a role for patients who go
for angiography to see what the coronary anatomy
is, to ascertain that there isn't a high risk anatomy,
for example, left main disease or three vessel disease.
If it's one or two vessel disease and the patient
was not severely symptomatic, no medical therapy
prior to that, with an ischemia evaluation that was
low to intermediate, one could make the argument
that the patient should be given a trial of medical
therapy to see whether or not the symptoms stabilized
before proceeding to coronary angioplasty. That facilitates
a conversation with the patient of what was found.
It allows for a discussion of what the likelihood
of clinical benefit would be for that patient, depending
upon what the symptoms and ischemia risk had been,
and it gives them an opportunity to see if the ischemia
risk or symptom burden is modified by being placed
on medications to begin with. Ultimately, it may
be better for the patient in the sense that, if the
symptoms are improved with just being on medications,
they could forgo a procedure that might cost them
20 or 30 percent of the co-pay, and potential bleeding
risk from being on dual antiplatelet therapy. That
doesn't mean that angioplasty is not beneficial to
patients in all circumstances; it just means that
we may need to not be as robotic or automatic in
just proceeding to angioplasty.
Q: You talk about a “discussion”.
Do you think this should be more of a collaborative
decision between patient and physician?
Dr. Chan: Yes…and it takes the onus off the
interventionalist, because it engages the referral
physician, the general cardiologist, the internist,
in having that discussion with the patient. So the
interventionalist does not always open up every lesion
that is seen, simply because he can, but ensures
that this is something that ultimately can help patients
feel better. We know for the vast majority of the
elective setting patients, where there's no high
risk coronary anatomy, the only benefit really to
be had is symptom relief, health status improvement.
If the patient is not severely symptomatic and those
symptoms can be avoided by being on maximal medical
therapy, then that might be the right way to go for
patients. This is really the type of patient that
we would think of in the COURAGE study.
But I think in order for this to really be realizable,
we need a multi-prong approach, and it can't just
be in the cath lab where that quality of improvement
occurs. We need to also engage the referral physician
base to better understand what the role of angioplasty
and diagnostic angiography is, and how we should
really get patients involved in the decision-making
process itself, and really get general cardiologists
to feel like they're part of the process of treatment.
"The
sub-specialty of cardiology should really
be applauded in taking the leadership in
looking at these hard questions.... Whether
it's ICDs or angioplasty or stress testing.
It really starts the conversation of how
to improve quality...and that is
a remarkable effort, knowing that sometimes
it may lead
to some revenue decreases for members of
the field itself." |
|
Q: Final
thoughts on what this study means for interventional
cardiology?
Dr. Chan: One of the things we should remember all along is that
the sub-specialty of cardiology should really
be applauded in taking the leadership in looking
at these hard questions, and in doing self-reflection
as to quality internally. I can think of no other
sub-specialty that is doing it at the level that
cardiology has been doing over the last decade,
whether it's ICDs or angioplasty or stress testing,
they're developing appropriate use criteria and
assessing rates of procedural appropriateness.
It really starts the conversation of how to improve
quality, how do we address issues of potential
overuse, and ultimately, how can we improve the
care that we deliver to patients. And that in
itself is a remarkable effort, knowing that sometimes
it may lead to some revenue decreases for members
of the field itself. |
Having said that, I think moving forward, we need
to think in a novel way about how we can develop
both real-time and non-real-time decision tools that
can guide clinicians who either perform the procedure
or who order the procedure to better understand that
some procedures are not going to likely benefit patients.
When a patient is referred to diagnostic angiography,
we already know their symptoms. We already know their
ischemia test results, if they had one. We already
know whether or not they're on medical therapy. And
so, you can envision physician tools, either at the
point of referral or in the cath lab. Based on coronary
anatomy, you already know whether or not a procedure
would be considered appropriate, uncertain, or inappropriate
by the Appropriate Use Criteria. And having that
front and center, for both referring physicians and/or
the interventionalists, may help better guide understanding
of whether or not we're utilizing resources well,
and what the threshold, perhaps, of even treating
or sending these patients to diagnostic angiography
should be.
Ultimately, it'll require
a commitment by both hospitals and physicians to
take on this effort, to really
decrease procedures that may be truly inappropriate,
and therefore ensure that patients are not harmed.
What we think the most important use of the Appropriate
Use Criteria will be, really, is to better understand
whether or not one hospital’s rate of inappropriate
procedures are high and is an outlier relative to
other hospitals. And if a hospital finds itself in
that situation, it may be worthy for them to really
better understand what's going on, because it's unlikely
that a hospital, if the national average in a hospital
for inappropriate rates for elective settings is
about 11% and one hospital is 25, 30%, it's unlikely
that it's really just differences in patient mix,
but it may be that there's just potential overuse
in those settings.
Q: And the fix for that would be?
Dr. Chan: I think what the NCDR has been doing, starting
in May, is now providing on a quarterly basis,
the rates of appropriate, uncertain and inappropriate
procedures for acute and non-acute indications.
It also provides a line-by-line item list of all
the inappropriate cases for the last quarter at
that hospital. Hospitals should then go back to
the data themselves and look at who those patients
were. The report now provides the actual appropriate
use criteria indication, to which these patients
were mapped, and to better understand whether or
not there's a pattern of quote-unquote “inappropriate” cases
at that hospital. And certainly the physicians
or hospitals may disagree with the appropriate
use criteria, but certainly, if other hospitals
are performing rates that are much lower, it's
just that that hospital's performance may be somewhat
of an outlier, at least, for certain indications
for angioplasty.
1 Appropriateness
of Percutaneous Coronary Intervention ; JAMA.
2011;306(1):53-61.doi:10.1001/jama.2011.91
2 ACCF/SCAI/STS/AATS/AHA/ASNC
2009 Appropriateness Criteria for Coronary
Revascularization; J Am Coll Cardiol
2009;53:530 –53
This interview was conducted in July 2011
by Burt Cohen of Angioplasty.Org.
|